The SimBioSys team needed an eQMS which was quick and easy to implement and start using.
Qualio delivered that potential, with the first users logged in within a month and a complete QMS built into the software in just 90 days.
Everyone in the team, from staff to contractors and consultants, now use Qualio for document access and training activities, from HR and HIPPA to privacy, day-to-day SOPs and ISO 13485 readiness.
Since SimBioSys are pursuing multiple standards simultaneously, Qualio's document functionality became invaluable, connecting key documents with standard-specific tags and smart linking for a holistic, market-ready information library.
Information can be quickly and easily shared with third parties too, with Hilary noticing a 'collaboration factor' from using Qualio that simply wasn't possible with a paper-based QMS.
Hilary could also lean on the Qualio+ offering for extra quality and regulatory support, tapping the expertise of Sumatha to help the company's market preparations.
With faster, sharper processes and complete visibility of the quality landscape, Hilary, Michael and the team are enjoying guiding their products towards regulatory approval and opening a new chapter for the company.
And clunky, Excel-based medical device quality processes are now a thing of the past: